evaluation of breast cancer recurrence rates following surgery in women with ductal carcinoma in situ

Conditions: Breast Cancer

Summary: rationale: the evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer. purpose: study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.

objectives: * evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ (dcis) prognosis. * evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of dcis. * identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation. * evaluate patterns of salvage of recurrence and rates of breast conservation. * evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post dcis excision. outline: this is a registration study stratified by histologic grade (high vs low or intermediate) and adjuvant tamoxifen therapy (yes vs no). patients receive standard clinical and mammographic follow-up for greater than 10 years. if recurrence occurs, treatment will be at the discretion of the investigators. patients may receive adjuvant oral tamoxifen daily for 5 years after local excision. a follow up magnification view mammogram must be taken after the last local excision, and microcalcification must be negative. patients are followed every 6 months for the first 10 years, and then annually thereafter. projected accrual: 1000 (500 per stratum) eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year.

Eligibility criteria:
disease characteristics: * histologically proven low or intermediate grade ductal carcinoma in situ (dcis) of the breast * no greater than 2.5 cm in the greatest dimension * or * histologically proven high-grade dcis of the breast * no greater than 1 cm in greatest dimension * region of dcis must be at least 2.5 mm in greatest dimension (mammographic estimate of size allowed where pathologic measurement is impossible) * dcis must be non-palpable; detected by a mammogram or found incidentally by a breast biopsy * pathologically confirmed negative margins of at least 3 mm * breast must be suitable for breast conserving therapy * proper tumor size versus breast size * no carcinoma or suspicious mammogram findings in other breast sites * no prior in situ or invasive breast cancer * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * greater than 5 years hematopoietic: * not specified hepatic: * not specified renal: * not specified cardiovascular: * not specified other: * no other invasive malignancies within the past 10 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix * no known hiv infection * no paget's nipple disease prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * adjuvant tamoxifen allowed radiotherapy: * no prior radiotherapy to breast * no adjuvant radiotherapy surgery: * not specified

Keywords: breast cancer in situ ductal breast carcinoma